Regulatory Compliance Solutions

  1. FDA 21 CFR Part 11-Compliant Software 2/28/2023

    Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?

    Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.

  2. Optima™ XPN Ultracentrifuge 6/16/2023

    1,500 mL max rotor capacity 100,000 max RPM 802,400 x g

    Security and tracking Remote monitoring and control eXPert simulation software.

  3. A First-Of-Its-Kind Advanced Qualification Dossier 10/29/2024

    This unique and comprehensive “On-Demand” dossier is designed to address the qualification requirements and provide all the information needed for your specific assembly in one location.

  4. Enterprise Calibration Management 8/8/2025

    Optimize calibration processes with a paperless, enterprise-ready platform to ensure compliance, improve accuracy, and boost efficiency with automated workflows and KPI insights.

  5. Global Technical Services 10/15/2024

    From risk assessment to bio-decontamination solutions, drive continuous improvement in contamination control with tailored expert support.

  6. Pharmaceutical Automation And Information Technology Services 12/21/2020

    As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.

  7. Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements 4/14/2023

    As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.

  8. Pharmaceutical Change Control Software 3/22/2023

    Using Document Change Control Software in Regulated Environments

    Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.

    In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.

  9. Regulated Document Review 3/24/2025

    Enables secure real-time document review, co-authoring, and redaction in order to shorten the document review process by up to 65%.

  10. IDBS PIMS And Regulatory Compliance 4/4/2025

    Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures: IDBS PIMS has been designed, developed and tested to enable compliance to 21 CFR Part 11 to accommodate the regulatory needs of its users.